SUMMARY

The sponsor submitted five
published and three unpublished studies of varying quality that assess the
effects of advance provision of emergency contraception on sexual and contraceptive
behaviors. When reviewing these studies as a body of evidence, the quality or
applicability of each study must be considered.While most of the studies state that they were randomized, only one
study (Ellertson) used a random number generator as the method of
randomization. The other studies used systems such as date of clinic visit or
other less desirable systems. The two unpublished studies would not have
received peer review (although Gold et. al was recently accepted for
publication by the Journal Of Pediatric and Adolescent Gynecology).Three of the studies were performed in
foreign countries and may have limited generalizability to the United
States. The overall summary of eight
behavioral studies is presented below and in Table 1 followed by the individual
reviews.

STUDY DESIGN

1.Study Location: Five studies were
conducted in the USA
and one each was conducted in the UK,
Africa and India.

2.Subjects: All subjects in the eight
studies were recruited from family planning clinics (the purposes for visiting
the clinics were EC consultation, post-abortion follow-up and postpartum
evaluation). The age range was 15-45 years with most enrollees being around 20
years old.

3.Study Groups: Subjects were randomly
(in most studies) assigned to the following 2 or 3 groups. All subjects
received education regarding emergency contraception use (this is in
contradistinction to the actual use study submitted by the sponsor where
education was not given to the subjects enrolled in the study, thereby more closely
mimicking an OTC environment).

Advance EC
Group:
Subjects received in advance one course of EC pills in six studies and three
courses of EC pills in two studies (one in US and one on India);

Control
Group:
Subjects received EC education only (including advice on where to get and how
to use EC) except for one study where EC education was not given in the control
group;

Pharmacy
EC Access Group: Subjects received EC when needed from pharmacy in one US study (in California).

4.Sample Size: Number of subjects
ranged from 160 to 1020 in the five US
studies and 210-1083 in three studies outside US.

5.Follow-up Period: Subjects were
followed from 8 weeks up to 1 year after admission to the studies.

RESULTS

1.EC Use: All studies suggest that the
advance EC provision increase EC use.This supported the hypothesis of the studies that easier access would
translate into increased use.

2.Unprotected Sex: In these studies,
unprotected sex was defined as lack of use of a contraceptive.All studies demonstrated that compared to
baseline, the advance EC group and control group had decreased frequency of
unprotected sex.In some studies, the
decrease in unprotected sex was greater in the control group.

3.Condom Use: One US
study (sponsored by Women’s Capital Corporation) suggests that the advance,
pharmacy and standard EC access groups plus EC education had an increase in
more effective methods of contraception with a corresponding decrease in condom
use. The other 6 studies either demonstrated no significant decrease in condom
use with advance EC provision or in education alone (control groups) or
demonstrated that “used condoms every time” increased in treatment and control
groups when compared to baseline.

4.Consistent Use of Regular Contraception: Most
of the studies demonstrate that women in both the treatment and control groups
increase their use of a regular contraception compared to baseline.One US study suggest that women with advance
EC access are more likely to use less-effective contraception (although they had
less unprotected sex compared to baseline and increased “condom use every time”
from 12% at baseline to 47% at study completion), and another US study showed
higher frequency of missing oral contraceptive pills in subjects provided with
advance EC than those in control.

COMMENTS

1.These studies were not conducted in a simulated OTC
setting.However, several of the studies
would have recruited a similar subject population as that used in the actual
use study.The main difference in design
would be that subjects in the literature review would have received education
compared to the subjects in the actual use study and would have received an
advanced provision of EC.

2.Subjects were recruited exclusively from clinic sites
and received EC education during enrollment (except one study in which control
subjects did not receive EC education), which can not be generalizable to the
OTC population.

3.Study population in each study was a subset of general
population and was heterogeneous among all these studies. This diversity is
desirable reflecting many subgroups and capturing the many aspects of an OTC
population.The similarity of results is
also reassuring in that the different subsets tend to exhibit the same
behavioral trends.

4.Most studies provided only one course of advance EC. In
those studies, after the one course of EC pills were used, subjects in the
advance EC group would have the same accessibility to EC as the control group.

5.Subjects recruited and studies conducted outside US may
not be extrapolated to US
population.

6.There were limitations of design and/or methodology of
the studies and conclusions should be considered in that context.

CONCLUSION

1.The literature review studies suggests that the advance
access of emergency contraception did not increase the likelihood of
unprotected sex in women populations who visited family planning clinics. The
study duration’s ranged from 4-12 months in follow-up.The results may provide certain supportive
evidence to resolve some issues raised from the actual use study (such as
whether consistent use of routine contraception persist greater than the one
month of observation in the actual use study data submitted by the sponsors).

2.The studies did not simulate an OTC setting although
some of the studies have recruited similar subject populations as those
enrolled in the actual use study.

3.Most of the studies demonstrate that women in both the
treatment and control groups increase their use of a routine contraception
(less unprotected sex) compared to baseline.

4.Most of the studies either demonstrated no significant
decrease in condom use with advance EC provision and control groups or
demonstrated that “used condoms every time” increased in treatment and control
groups when compared to baseline

Information
in the table is extracted and summarized from the individual literature reviews
as attached in the following pages.

The
Advance EC (AEC) or the Advance EC Provision (AP) or Treatment(Tx) group : Subjects received EC pills in advance plus EC
education at the enrollment.

The
Controlor Standard EC access (SA)
group: Subjects received only EC
education (except the Jackson’s study, Literature #3) and were advised to request
EC pills from the clinics (the same sites as the advance group) by prescription
when needed.

The
Pharmacy EC Access(PA) group: Subjects received EC pills from pharmacy without
prescription.

Research assistants interviewed subjects at enrollment and
at follow-up (at 4 month by telephone or clinic visit) using a questionnaire to
obtain demographic information and to measure outcomes, including contraceptive
methods and patterns of use.

Data Analysis

All
analyses were conducted using the intent-to-treat population, with all study
subjects analyzed according to their initial group assignment. Differences
between Treatment and Control were analyzed with a Chi-square test for
categorical variables and t tests for continuous variables. A multiple logistic
regression analysis was used to determine the effect of advance provision of
emergency contraception on use at follow-up.

RESULTS

Subject Demographics

Only
age and race/ethnicity were reported in the article, as summarized in Table 1.
The mean age was 19 years (64% adolescents). Most subjects were minorities. The
demographic distribution between 2 groups was similar.

Table 1. Demographics of Subjects

(% of enrolled subjects)

Demographic

Treatment

n=130

Control

n=133

Total

n=263

Mean
age (years)

19.2

18.8

19.0

Race
or ethnicity

Hispanic

33.1

30.1

31.6

Black

26.2

31.6

28.9

White

16.9

12.8

14.8

Asian

14.6

16.5

15.6

Other
(biracial)

9.2

9.0

9.1

Primary
language Spanish

16.2

14.3

15.2

Data
were extracted from the author’s Table 1.

Baseline Characteristics

At
enrollment the sexual activity, contraception, pregnancy history and reasons
for clinic visit were comparable between treatment and control groups (Table
2), except that the history of unprotected sex was lower in the treatment group
than in control group (15% vs. 24%). The most common contraception method used
by the study population was condoms, and a higher proportion of subjects in the
treatment arm reported at baseline that they used condoms for contraception
than in the control arm (47% vs. 39%).At baseline a higher proportion of the subjects in the control arm
reported that their use of either condoms or oral contraceptives was consistent
(used condoms every time, never missed pills) than subjects in the treatment
arm.Consistent condom use was reported
in 24% of control subjects who used condoms compared to 12% on the treatment
arm.Consistent use of oral
contraceptives was reported in 42% of the control subjects who used oral
contraceptives, compared to 25% on the treatment arm.

The
table below demonstrates that the subjects in the treatment arm reported higher
frequency of sexual acts, higher proportion of condom use as a method of
contraception, lower rate of unprotected sex, higher proportion with a history
of elective abortion, higher proportion with a history of pregnancy and more
births.More subjects in the treatment
arm presented to the clinic visit for an “infection check”.

Table 2. Baseline Traits of Subjects
at enrollment

(% of enrolled subjects)

Baseline Characteristics

Treatment

n=130

Control

n=133

Total

n=263

Reason for clinic visit*

Papanicoloau
smear or check-up

16.2

19.5

17.9

Contraception

39.2

32.3

35.8

Follow-up
abortion

7.7

6.8

7.2

Pregnancy
test

37.7

44.4

41.4

Infection
check

20.8

13.6

17.1

First visit to clinic

38.8

40.6

39.7

Pregnancy History

Ever
pregnant

56.2

47.4

51.7

Ever
gave birth

20.8

16.5

18.6

Ever
had an elective abortion

40.8

34.6

37.6

History of sexually transmitted disease

18.6

18.0

18.3

Sexual Acts in past 4 months

None

3.8

5.3

4.6

Sporadic†

33.9

39.8

36.9

Once
a week

25.4

27.8

26.6

More
than once a week

36.9

27.1

31.9

New
sexual partner

23.1

21.0

22.0

Current contraception‡

Condoms

46.9

39.1

43.0

Oral
contraceptive

27.7

24.8

26.2

Depot
medroxyprogesterone acetate

10.0

11.3

10.6

Other

0.7

0.8

0.8

None
(unprotected sex?)

14.6

24.1

19.4

Dual
use (hormonal with condoms)

16.9

17.3

17.1

* Participant might have had
more than one reason for clinic visit.

† Sporadic: once or twice in
past 4 months or once to twice a month.

‡ Current contraception:
most effective method reported if more than one used.

Changes in Sexual and Contraceptive
Behavior (Table 5)

EC
Use:

·Women in the treatment group were significantly
more likely to use emergency contraceptives than those in control groups (20% vs. 7%, p=0.006).This difference between treatment arms
remained statistically significant in multiple logistic regression analyses
that evaluated the impact of contraceptive method, pattern of contraceptive use
at enrollment and frequency of unprotected sex reported at enrollment.

·Overall EC use increased from enrollment to
follow-up (4% vs. 14%) in both
groups, with more increase in the treatment group.

Routine
Contraception:

·Women in the treatment group were more likely to
have switched to a less-effectivecontraception methodthan those
in the control groups at the time of follow-up (28% vs. 17%, p=0.05).(Level of
effectiveness was ordered from most effective to least effective for this
analysis as follows:depot,oral contraceptive, barrier, none.)The proportion that didn’t change method or
continued to use no method at all was similar between arms at the time of
follow-up.

·Women in the treatment group tended to be less
likely to use more effective contraception than those in the control groups
(20% vs. 29%, p=0.1).

·The proportion of women in the treatment group
who reported consistent oral contraceptive (OC) use wasless than in the control group at baseline
(25% vs. 42%, p=0.08)Although the
proportion reporting consistent oral contraceptive use remained lower on the
treatment arm relative to the control arm at the time of follow-up (32% vs. 58%, p=0.03), the proportion of
subjects who reported consistent use increased in both groups at the time of
follow-up.

Unprotected
Sex:

·Overall “never had unprotected sex” (had
protected sex) increased at the follow-up as compared to that at the enrollment
(33% vs. 56%). As compared to the
baseline, increase in protected sex was 18% (from 32% to 50%) in the treatment
group and 28% (from 34% to 62%) in the control group (no statistical tests were
available).

·There were no significant difference at the time
of follow-up between treatment and control groups in the proportion of condom
use.

·Since there was less condom use at baseline in
the treatment group than in control group, the proportionate increase in condom
use in the treatment group was greater than in control group (4x increase vs. 2x increase).

Table 5. Contraceptive Behavior
during the Study Period Compared to Baseline

1.The subjects were not randomly assigned. This created
an imbalance at baseline (unprotected sex, condom use, missed OC pills and EC
use) and could have introduced bias into the study. This is a major flaw and
limits conclusions.

2.Only a single course of EC was provided to the
treatment group (advance provision), so the study observation may not truly
reflect changes in sexual and contraceptive behaviors that may occur in the OTC
setting.

3.Information on education, literacy level, and income of
subjects were not provided.Given the
non-randomized design there are no assurances of an even distribution of these
demographics.

4.Sample size was small (n=130 in the Advance group and
n=133 in the Control group).

5.Subjects were recruited from clinical sites and were
high risk, which may not be generalizable to OTC population.

CONCLUSION

This
study demonstrated the following: Compared to their baseline, women age 16-24
with advance EC provision are::

·Less
likely to have unprotected sex

·More likely to use condoms (every time)

·More
likely to use EC pills

·More
consistent with their use ofOC pills

·Compared to the control group, the women
provided with Advance EC were more likely to switch to a less effective routine
contraception method and have a higher proportional increase in condom use

When
compared to the treatment group, the control group was more likely to have a
greater absolute change in “Never had unprotected sex” and “Never missed
pills”. However, it should also be noted that at baseline, the treatment group
appeared to potentially be a higher risk group compared to the control group,
with a greater percentage of subjects that were presenting to the clinic for
contraception, infection checks, had been pregnant, had given birth, had an
elective abortion, had a new sexual partner in the past 4 months and had an
elective abortion.Because of these
imbalances at baseline, between group comparisons should be made with caution.

Literature #2: UCSF Study #H9738-18501-02

(Vol. 32/p134; EDR dated 2003-09-08)

Provision of
Emergency Contraception to Women enrolled in the study prior to December
31, 2001: Pharmacy
Access and Advance Distribution Evaluation

To compare the rates of unintended
pregnancy and sexually transmitted disease (STD) among three different
distributions (advance provision, pharmacy access and standard access) for
emergency contraception.

Secondary objectives:

To assess the effects of the three
different emergency contraception distribution methods on sexual and contraceptive
behaviors, such as the frequency of unprotected sex, and use of
condoms, oral contraceptives, and emergency contraception use.

METHODS

Subjects

Subjects were recruited from four
family planning clinic sites (Table 1) in the San Francisco bay area (CA) with the following inclusion and exclusion
criteria.

Inclusion Criteria

·Women age 15-24 at high risk for unintended pregnancies

·Speak either Spanish or English

·Be available in 6 months for a follow-up visit.

Exclusion Criteria

·Women were currently pregnant;

·Actively trying to get pregnant;

·Sterilized; using Depo-Provera, IUD, Norplant or Lunelle;

·Reported having had unprotected sexual intercourse in the
past 3 days.

·Women who presented to the clinic specifically requesting
emergency contraception (the rationale
was not specified)

One-way
analysis of variance, contingency table analyses, and a Chi-square test were
used for different variables. In cases of small numbers, when cells had fewer
than 5 observations, the Fisher’s exact test was conducted. All analyses were
evaluated at the two-tailed probability level of p<0.05 and no adjustments
were made for the number of analyses or pair-wise comparison.

RESULTS

Subject Demographics

Demographic characteristics of the enrolled subjects are
summarized in Table 2. Overall they were comparable among the 3 study groups.
Races (white, black, Latina, and Asian) were evenly distributed among 3 groups. The
following were the major characteristics:

Mean age: 20±2.6
(15-24) years

Marital status:86%
single

Active sex (within 6 months):100%

Unprotected intercourse (within 6 months):50%

Currently using condoms:67%

Currently using oral contraceptives:41%

Previous emergency contraception:35%

Education and literacy level: unknown
(not reported).

A third of participants reported having been pregnant
previously, with 9% reporting ever given birth.

Follow-up Compliance

Approximately 92% of subjects (936 of 1,020) in each
group completed follow-up assessment within one year (211±39 days) (Table 3).

Table 2. Demographics
of subjects

Demographics

Pharmacy

Access

(N = 314)

Advance

Provision

(N = 316)

Standard

Access

(N = 306)

Total

(N = 936)

Age
(years)

Mean ± SD

19.7 ± 2.6

19.7 ± 2.6

19.9 ± 2.6

19.7 ± 2.6

Race

Latina

66 (21.0)

64 (20.3)

60 (19.6)

190 (20.3)

Black

53 (16.9)

54 (17.1)

52 (17.0)

159 (17.0)

White

79 (25.2)

100 (31.7)

83 (27.1)

262 (28.0)

Asian/Pacific
Islander

57 (18.2)

62 (19.6)

69 (22.6)

188 (20.1)

Multiracial

48 (15.3)

29 (9.2)

35 (11.4)

122 (12.0)

Other

11 (3.5)

7 (2.2)

7 (2.3)

25 (2.7)

Marital
Status

Single

263 (83.8)

273 (86.4)

271 (88.6)

807 (86.2)

Cohabiting

42 (13.4)

31 (9.8)

28 (9.2)

101 (10.8)

Married

7 (2.2)

10 (3.2)

6 (2.0)

23 (2.5)

Married, but
separated

2 (0.6)

-

-

2 (0.2)

Divorced

-

2 (0.6)

1 (0.3)

3 (0.3)

Widowed

-

-

-

-

Data
were extracted from the author’s Table 5 (p7) and presented as “No. (%).”

Table 3. Subject Disposition at
Follow-up

Disposition

Pharmacy
Access

No. (%)

Advance
Provision

No. (%)

Standard
Access

No. (%)

Total

No. (%)

Enrolled Subjects

343

340

337

1020

Lost to Follow-up

23 (6.7)

23 (6.8)

27 (8.0)

73 (7.2)

Refused Follow-up

6 (1.8)

1 (0.3)

4 (1.2)

11 (1.1)

Completed

Follow-up*

314 (91.6)

316 (92.9)

306 (90.8)

936 (91.8)

* Mean follow-up days (post-baseline) was 211±39 days,
median follow-up days: 195 days. There were no statistical differences in
demographics of subjects between Lost-to-Follow-up and Completed-Follow-up.

Sexual and
Contraceptive Behavior

Pregnancy:

The overall pregnancy rate (Table 4) in the 936 subjects who
completed the follow-up interview was 8%. There were no differences in
pregnancy rate among 3 groups including when analysis was controlled for
baseline history of pregnancy (p<0.89, Chi-square test).

Sexually Transmitted Diseases (STDs):

Subjects were considered to have acquired an STD during the
follow-up period if they were positive for herpes (new diagnosis), chlamydia,
gonorrhea (self-reported or by
laboratory tests),trichomonas, PID
(self-reported). There were no differences in STD acquisition among 3 groups
when controlling for baseline history of STDs (p<0.427, Chi-square test).

Overall
29% (269 of 936) of subjects used emergency contraception during the study
period.

1.Subjects were more likely to use emergency
contraception in the Advance Provision group (39.2%) than in the Pharmacy
Access group (26.5%) or in the Standard Access group (20.3%); they were also
more likely to report convenience of emergency contraception compared to those
in the Pharmacy Access group or the Standard Access group (96%, 87% and 87%,
respectively).

2.There were no differences in the time to take the first
pill among the 3 groups or in overall proper use of emergency contraception
(p>0.05). Subjects in the Standard Access group tended to have higher
correct use than other 2 groups, 97% (SA), 92% (AP) and 90% (PA), and were more
likely (100%) to take the second pill than the Advance Provision group (93%)
and the Pharmacy Access group (90%).It
should be noted that the time interval for use of the second pill was not
defined in this studyas it was in the
actual use study (12 hours after first pill).

3.The proportion of repeat use was highest in the Advance
Provision group.The baseline EC use was
35% for the entire study population.

Table 5. Emergency Contraception Usage during Study

EC Use

Pharmacy

Access

(N = 314)

Advance

Provision

(N = 316)

Standard

Access

(N = 306)

All Subjects

(N = 936)

Total*

83
(26.5)

124
(39.2)

62
(20.3)

269
(28.8)

Never

230 (73.5)

192 (60.8)

244 (79.7)

666 (71.2)

One time

52 (16.6)

75 (23.7)

45 (14.7)

172 (18.4)

Two times

20 (6.4)

28 (8.9)

13 (4.3)

61 (6.5)

> 3 times

11 (3.5)

21 (6.7)

4 (1.3)

36 (3.8)

Data were
extracted from the author’s Table 10 (p13) and presented as “No. (%).

Overall 96.6% (903 of 936) were sexually active during the
study period.

1.There
were no statistically significant differences in the rates of unprotected sex
among the 3 groups. Subjects in the Advance Provision group tended to have
higher frequency of unprotected intercourse (47% in AP, 41% in PA and SA).

2.As
compared to the baseline, the frequency of unprotected sex decreased in all
three groups. This change was
statistically significant in the SA and PA groups but not in the AP group
(Decrease from 50% to 41% in PA, and from 53% to 41% in SA, p< 0.01 by
McNemar’s test; but from 49% to 47% in AP, p=NS).

There were no statistically significant differences in
condom and OC uses among the 3 groups during the study period.

1.Overall
condom use decreased in all 3 groups as compared with the baseline; condom use
“at last sex” significantly decreased in the Advance Provision and the Pharmacy
Access groups (P< 0.01), but remained relatively stable in the Standard
Access group (p< 0.65).

2.During
the same period that condom use decreased, there were increase in “currently
using” OC in all groups compared to the baseline.The “Use at last sex” increased in all groups
(PA change=37% to 51%, AP change=40% to 48% and SA change=38% to 46%).

Age difference:

There were no significant differences in observed parameters
(pregnancy, condom use, unprotected sex, routine OC use) between adolescents (15-17
years old) and adults (18-24 years old).

COMMENTS

1.The proportion of 15-17 year olds and the literacy
level of subjects were not provided.

2.“Baseline” STDs were reported, but the exposure period
over which an infection was acquired was not captured. However, STDs acquired
during the study among the 3 groups were comparable and were lower than the
“baseline” history.

3.Overall unprotected intercourse decreased in all three
groups compared to baseline. This change was statistically significant in the SA
and PA groups but not in the AP group (from 50% to 41% in PA, and from 53% to
41% in SA, p< 0.01 by McNemar’s test; but from 49% to 47% in PA, p=NS).

SUMMARY

1.Advance Provision did not increase STDs as
compared with the Pharmacy Access and the Standard Access to EC.

2.Subjects in the Advance Provision group were
more likely to use EC pills as compared to the Standard and Pharmacy Accesses.

3.All three groups had
less unprotected intercourse during the follow-up as compared to baseline. When
compared to baseline, the PA and SA groups decreased more (P<0.01) than the
advance EC provision group (p=NS).

4.All three EC accesses
were associated with a decrease in condom use, with statistically significant
decreased differences in “use at last use” among the Advance Provision and the
Pharmacy Access groups. However, thedecrease in condom use was offset with increased oral contraceptive use.

5.Although there was
greater OC use at study end compared to baseline for “use at last sex” and
“currently using” in all 3 groups the proportion in all three groups who
reported “missing OC pills” at study end compared to baseline increased.

CONCLUSION

Advance Provision of emergency contraception was not found
to be associated with a difference in pregnancy rates or acquired STDs compared
to Pharmacy Access or Standard Access.Advance Provision decreased unprotected intercourse compared to
baseline, but to less of an extent that the Pharmacy Access or Standard Access
groups.All three groups had increased
OC use and decreased condom use.All
three groups had increased “missing oral contraceptive pills” compared to
baseline at study end.The highest rate
of unprotected sex was in the AP group (49% vs. 41% in the PA & SA groups).

Literature #3(sNDA 21-045, Serial No. 105, p5162)

Advance Supply of Emergency
Contraception: Effect on Use and Usual Contraception—A Randomized Trial

Author:Rebecca
A. Jackson, Eleanor Bimla Schwarz, Lori Freedman, and

Philip Darney

Affiliate:Center for Reproductive Health Research and Policy
and Department of Obstetrics, Gynecology, and Reproductive Sciences, and
Division of General Internal Medicine

Department of Medicine, UCSF, and San
Francisco GeneralHospital,
San Francisco, California.

Sponsor:Partially funded by an unrestricted grant from
the Packard Foundation. The Packard Foundation is a nonprofit organization.

They provided funds for supplies
and oral contraceptive pills.

Study Location: USA,a public inner-city hospital in San Francisco

From September 1998 through March 1999

Publication:Obetet Gynecol 102: 8-16,
2003

Design:Randomized (by date of
discharge) controlled clinical trial

1 year
observation

Single course of
advance EC provision

METHODS

Subject:A total of 370 postpartum women were enrolled from
a public inner-city hospital (San Francisco, CA)
from September 1998 through March 1999, with the following eligibility
criteria:

Age: (was not
specified in the Method)

Postpartum women (had a live birth)

Spoke English or Spanish

Available for follow-up in 1 year

Had not undergone a postpartum tubal ligation

Subjects
were randomly assigned to the following 2 groups:

Advance
Provision Group: 184 subjects received one course of EC pills and EC
education. The one course EC contained 8 oral contraceptive pills containing
0.15 mg of levonorgestrel and 30 ug of ethinyl estradiol. The educational
session was a 5-minute intervention and included instructions for obtaining
additional emergency contraception pills if needed.

Control
group: 186 subjects received only routine contraceptive counseling, and
this did
not usually include EC education.

To
prevent interference of the difference education’s that provided to each group,
the investigators enrolled all women on a given day to the same group.

Data Collection:
A Kaiser Family Foundation Questionnaire (survey) was the data collection
instrument. The questionnaire was administered in person at enrollment and by
phone at 6 and 12 months. The primary outcome was self-reported use of
emergency contraception. Secondary outcomes included change in use of other
contraceptive methods and knowledge about emergency contraception.
Contraceptive and sexual behaviors were assessed by asking about types of
contraception used and consistency of use.

Data Analysis:The individual subject was used as the unit of analysis.
Differences between groups and differences within each group over time were
analyzed using the Fisher exact test, Student t test, or the McNemar test.

RESULTS

Subject Demographics

Of
721 screened subjects, 370 were enrolled and randomized to the Advance EC group
(184) and Control group (186). The demographics and baseline characteristics of
the enrolled subjects are summarized in Table 1; there were no statistically
significant differences between the two groups. Approximately 18% were teens;
72% were Latina; 43% married. About
half had a high school education.

Follow-up Compliance

At 6
months after enrollment, follow-up was available for 78% and at 1 year, 69%.
Overall, 85% were available for at least one follow-up session. There were no
differences between groups in the proportion lost to follow-up; nor were there
differences in baseline traits between those lost to follow-up and those who
completed the study (Table 1).

Sexual
and contraceptive behaviors of subjects during 6 month period before and after
enrollment in both groups were summarized in Tables 2 and 3.

Unprotected
sex:

·Half the women in both groups reported at least
one episode of unprotected intercourse during the 1-year follow-up period with
no significant differences between groups, although the proportion was somewhat
lower on the EC arm.

EC
use:

·Women in the Advance EC provision group were
significantly more likely to use ECPs during the study (13% vs 2% at one year).

·Subjects in both groups became more
knowledgeable about emergency contraception during study periods; the Advance
group demonstrated the greatest increase in knowledge.

·Five subjects used multiple doses of EC over the
one year period, and three of them were in the Advance EC group.

·Approximately 25% of the study subjects could
state the correct timing for using EC pills, which was consistent with results
(18% correct use) from another study (Endres et al: Experience with
self-administered emergency contraception in a low-income, inner-city family
planning program. J Reprod Med 2000;45:827–30).

Condom
use:

Among
exclusive condom users, there was an increase in the use routine (“use mostly
or always”) of condoms in both groups as compared to the baseline.The proportion of routine condom use was
similar between groups at follow-up although the proportional increased from
baseline was greatest in the control group.

Primary
contraception:

As compared to baseline, there was a significant
improvement in contraceptive use (more effective methods and consistency) in
both groups during the 12-month follow-up, similar between groups.

COMMENTS

1.The study population, postpartum women from an
inner-city hospital, is not completely generalizable to the spectrum of
sexually active women expected in an OTC setting.

2.Only a single course of EC was provided to the Advance
provision group, and few requested additional EC pills during the study.

3.There were not observed differences between the Advance
EC group compared to the control group regarding unprotected intercourse rates
at 6 month and 12 months..

4.Randomization procedure was by date of discharge was
not ideal and the sample size was small (n=370).The majority of the study population was Latina
postpartum women.

CONCLUSION

Advance EC access in the postpartum women during the 1-year
observation:

1.Increases EC use

2.Did not adversely change routine contraception,
including condom use. The advance EC group maintained similar contraception use
as the control group.Routine
contraception use increased in Advance EC and Control groups.

3.Did not increase the frequency of unprotected
intercourse as compared to control subjects and over time.

Table 2. Use and knowledge of
Emergency Contraception

(% of subjects who provided data)

Outcome

Baseline

At 6 months

At 12 months

Advance EC

N=184

Control

N=186

Advance EC

N=138

Control

N=149

RR

(95% CI)

Advance EC

N=128

Control

N=128

RR

(95% CI)

Use of EC in
prior 6 months

Use at least once

3

3

10

3

3.56 (1.19,
10.7)

13

2

5.21 (1.55, 17.5)

New users of EC

8

1

6.03 (1.36,
26.7)

10

2

4.17 (1.21, 14.4)

In those with any unprotected intercourse

22

3

7.74 (1.81,
33.2)

16

3

5.14 (1.14, 23.1)

General EC
knowledge†

Has heard of “EC” or “MAP”

34

38

90

47

1.91 (1.59,
2.29)

91

70

1.31 (1.16, 1.49)

Salient knowledge about EC

18

20

70

32

2.14 (1.66,
2.77)

71

52

1.38 (1.13, 1.69)

Data were extracted from
author’s Table 2.

† “Heard of EC” indicates
familiarity with the name “emergency contraception” or “morning-after pill.”
“Salient knowledge” indicates the subject was able to correctly name or
describe EC pills.

‡Condom use mostly or always in
those who use only condoms. Numbers in EC and control at baseline,
respectively: n = 54, 53; at 6 months: n = 38, 40; at 12 months: n = 31, 36; however, calculation of the percentages on
this event in the Table was not specified in the report.

*The frequency of unprotected
intercourse at baseline was not reported.

Adolescent mothers were recruited and enrolled from a large
urban city (location and sites were not specified), age 14–20 years and not
desiring pregnancy. Exclusion criteria were not reported. The subjects were
randomized into the following 2 groups:

Treatment groups:subjects received an advance supply of
levonorgestrel-only EC;

Control group: subjects received education on emergency
contraception alone.

Data Collection

Subjects were contacted by phone at 6 months to collect the
following data with a questionnaire: hormonal contraception use, condom use,
sexual activity, unprotected sex, EC use, reasons for not using EC and
pregnancy.

Data Analysis

Chi-square
tests were conducted to assess differences between groups. Odds ratio and 95%
CI were calculated to determine the association between contraceptive use and
group assignment at baseline and follow-up.

RESULTS

Subject Demographics and Follow-up
compliance

A
total of 160 adolescent mothers were enrolled (number of screened subjects
was not provided); their compliance with follow-up contacts at 6th
and 12th month after enrollment is summarized in Table 1.

Table 1. Subject enrollment and
follow-up compliance

Subject

Treatment

Control

Total

Enrollment

82

78

160

6th month
follow-up

57

54

110
(69%)*

12th month
follow-up

42

46

88
(55%)*

*
% of enrolled subjects.

Demographics:

Mean age:14-20
years

Hispanic:83%

African American:16%

Education: unknown

Changes in Contraceptive Behavior

There
were limited data available in the abstract about sexual and contraceptive
behavior at baseline and follow-up (6th and 12th month)
from both groups. Table 2 was extracted from text of the abstract.

Unprotected
sex: The author stated that there were no increases in unprotected sex
in the treatment group; but no data were provided.

EC
use: Subjects in the treatment group were more likely to use EC.

Condom
use: The author stated that there were no changes in condom use at 6th
month between treatment and control groups, but no data were provided.

Primary
contraception: The author stated that there were no changes in primary
contraception at 6th month between 2 groups, but no data were
provided.

Table 2. Sexual and contraceptive
behavior

Treatment

One package EC

N=57

Control

Education only

N=54

Total

N=111

Sexually active

Baseline

ND

ND

59%

At
6th month

62%

57%

Unprotected sex

Baseline

7%

At
6th month

ND

ND

No
change

EC Use*

At
6th month

85%

19%

At
12th month

79%

21%

Pregnancies at 6th
month

4
(7%)

10
(18%)

Change in primary
contraception

OR = 0.77 Between group
comparison

(95% CI: 0.47-1.25)

Change in condom use

OR = 0.71 Between group
comparison

(95% CI: 0.32-1.57)

ND:
no data were reported in the abstract.

*
% of subjects who had unprotected sex.

COMMENTS

There were limited data
provided on primary parameters to evaluate changes of interest, particularly
condom use and unprotected sex.

Subjects were adolescent
mothers and may have limited generalizability to the OTC setting.

Only a single course of EC
was provided to the advance provision group, which did not reflect access
in an OTC setting.

Small study size may have
led to lack of observed statistically significant differences.

CONCLUSION

Advance
EC provision was reported not to decrease condom use and primary contraception
during the 6-month follow-up.

Literature #5(vol 13,
page 023)

The Effects of Advance
Provision of Emergency Contraception on Adolescent Women's Sexual and
Contraceptive Behaviors

Author:Melanie
A. Gold

Affiliate:University
of PittsburghSchool
of Medicine

Children's Hospital
of Pittsburgh, Division of Adolescent
Medicine

Sponsor:Laurel Foundation
(unknown location) for financial support.

Woman’s Capital
Corporation provided Plan B.

Study Location: USA,an urban hospital-based adolescent
clinic

Pittsburgh, PA from June 1997 to June 2002.

Publication:Unpublished Manuscript

Design:Single-center, randomized
clinical trial

8
months follow-up

Single
course of advance EC provision

METHODS

Subject

Sexually active female adolescents were recruited from the
waiting room of an urban hospital-based adolescent clinic in a Children’s
Hospital in southwestern Pennsylvania
between June 1997 and October 2001, with the following criteria:

Inclusion criteria:

Age 15–20 years

Available for
monthly follow-up by phone.

Exclusion criteria:

Live in a
foster-care or group home setting

Using
long-acting contraception (such as IUD, Norplant, Depo-Provera)

OC users
were not excluded.

Of 779 screened adolescent women, 301 (39%) were enrolled
and randomly assigned to the following 2 groups:

Advance EC group: 150 subjects received EC education
information and one course of EC pills, and were informed that they could
obtain up to 2 additional EC courses during 6 months. Yuzpe (Jun 1997 – March
2000) and Plan B (after March 2000) were used.

Control group: 151 subjects received EC education information
and were told how to request EC from the adolescent clinic (the same regimen as
the Advance EC) if/when needed.

Data Collection

Self-reported sexual, contraceptive behavior, pregnancy,
STDs and EC use for the past month and at last episode of intercourse were
collected monthly by telephone interview for 6 months after enrollment. At
least 5 attempts were made to reach each subject for monthly interview. EC
knowledge was assessed at month 1 and 6 interviews only.

RESULTS

Subject Demographics

The
following are major demographic characteristics. They were comparable between
the 2 groups.

Approximately
85% of enrolled subjects at month 1 and 65% at month 6 were interviewed. The
median length of follow-up was 252 ± 32 days from enrollment. The follow-up compliance between the
2 groups was comparable.

Changes in Sexual and Contraceptive
Behaviors

Sexual
and contraceptive behaviors of subjects from the Advance EC and control groups
at the 1st and 6th month after enrollment are summarized
in Table 1. In the original Table, the author did not indicate how the
percentages were calculated. Therefore, this reviewer compiled the data from the
original table using the number of subjects who completed interview as a
denominator (Table 1). The trends of the results are similar to the original
presentation.At study entry 20% of
subjects had a history of pregnancy, 30% had a history of STD, and 69% reported
awareness of EC.Twenty-five percent
reported their last intercourse was unprotected, 73% reported condom use and
38% reported OC use.

Table 1. Sexual and contraceptive
Behaviors

[No. (% of subjects who completed
interview)]

Behavior

First Month Follow-up

Sixth Month Follow-up

Advance EC

Control

Advance EC

Control

Enrolled Subjects†

150

151

150

151

Completed Interview†

123 (82)

131 (87)

91 (61)

105 (70)

EC Use‡

(15)

(8)

(8)

(6)

STDs‡

12 (13)

12 (11)

In past month

Unprotected intercourse

24 (20)

28 (21)

16 (18)

19 (18)

Used condom

73 (59)

85 (65)

70 (77)

65 (62)

Used OC pills

42 (34)

51 (39)

33 (36)

50 (48)

Used any hormonal contraception

42 (34)

51 (39)

40 (44)

56 (53)

At last intercourse

Unprotected

21 (17)

25 (19)

10 (11)

19 (18)

Used condom

70 (57)

80 (61)

67 (74)

66 (63)

Used OC pills

35 (28)

41 (31)

34 (37)

46 (44)

Used any hormonal contraception

35 (28)

41 (31)

39 (43)

50 (48)

Data
were extracted from the author’s Table 2, or Figure A (†) or text (‡).

The
denominators used for percentage calculation was not defined in original Table,
nor indicated in the report. The percentages in this table were recalculated
using number of subjects who completed interview as a denominator.

EC
Use:

At the first month, Advance EC group used EC more than
control group (15% vs. 8%, p=0.05); there was no difference between the 2
groups at the 6th month.In
multivariate analysis the only independent variable that predicted EC use was
past pregnancy.

During the entire study, 22 subjects (15%) in the Advance
EC group returned to request extra course of EC (17 returned once, 4 twice, and
one 3 times).The Advance EC group
reported more rapid first dose administration compared to the control group- 11
hours vrs 22 hours (p<0.005).

Unprotected
Sex:

At both the first and sixth month, there were not
differences in unprotected intercourse recorded for “in past month” or “at last
intercourse” between Advance EC and control groups. The proportion for both
arms at month 1 and 6 were slightly lower than the baseline rate of unprotected
intercourse, 25% on the Advanced EC arm and 24% on the control arm.

Contraception:

There were no significant differences in condom use, OC
pill use or injectable contraceptive methods between Advance EC and control
groups at one month. The proportion of EC subjects who reported condom use, 59%
decreased from the baseline 76%.At 6
months a higher proportion of EC subjects reported use of condoms, 77%, than
the control, 62% (p=0.02).At 6 months
the proportion of EC subjects reporting condom use had returned to the baseline
level.Over the course of the study,
there were 13(9%) pregnancies reported
by the advance therapy group compared to 18 (11%) pregnancies reported by the
control group.

STDs

There
were 12 subjects each in the Advance EC and control groups who reported a
newly-diagnosed STD during the study. By using number of subjects who completed
interview as a denominator, 10% of subjects in the Advance EC group acquired
STDs, compared to 9%.

COMMENTS

Data
process and analysis were not clearly presented.

Only
one course of EC was provided. Although the subjects could obtain an
additional 2 courses, few subjects returned for additional request.

Subjects
were interviewed monthly; however, only data from months 1 and 6 were
reported.

About
50% of eligible women declined to participate in the study due to “lack of
interest”.

Comparisons
between months 1 and 6 should be made with caution due to high attrition
rate in both groups at month 6.

CONCLUSION

Advance
provision of EC did not increase frequency of unprotected intercourse and did
not decrease condom use during the 6-month follow-up in women ages 15-20
compared to a control group.

Literature #6 (vol 13, page 012)

The Effects of Self-Administering
Emergency Contraception

Author:Anna Glasier and David
Baird

Affiliate:Edinburgh
Healthcare National Health Service Trust Family

Planning and Well
Woman Services

Department of
Obstetrics and Gynaecology

University
of Edinburgh, Scotland.
United Kingdom.

Financial Support:Chief Scientist’s Office

Scottish Home and
Health Department.

Study Location: UK, Family planning clinic and hospital
in Edinburgh

From
Jan 1994 to Dec 1996

Publication:New Eng J Med 339 (1):
1-4, 1998

Design:Randomized clinical
trial, randomized by birthdate

1-year
follow-up

Single course of
advanced EC provision

METHODS

Subject

A total of 1083 women, ages 16-44, were recruited from a
family-planning clinic and a large hospital in Edinburgh
(Scotland, UK)
between January 1994 and December 1996; 60% (650) were returning for follow-up
of prior EC consultations and 40% (433) were returning for follow-up after
therapeutic abortion.

Subjects were randomly assigned into the following 2 groups
(on the basis of their birthday (even-numbered birthdays were assigned to the
treatment group):

Treatment group: 553 women received one package of EC pills
(four pills, each contained 50 µg of ethinyl estradiol and 0.25 mg of
levonorgestrel), written instructions and telephone numbers to call with
questions.

Control group:530 women
received EC education and informed where to get and how to use emergency
contraception.

Data Collection

A questionnaire was sent to subjects one year after enrollment
to collect information about EC use, other contraception methods, and
pregnancy.If EC was used subjects were
to mail in a notification card with time of administration relative to
intercourse and date of last menstrual period.They were also instructed to go to the clinic within one week after the
date of expected menstrual period.At
that time she was given a replacement packet.

Data Analysis

Differences
between the groups were tested by chi-square tests with Yates’ correction for
binary factors or Mann–Whitney tests for ordinal factors.

RESULTS

Subject Demographics

Only
age and education of subjects were reported (Table 1). Twenty-three percent of
subjects were age < 20 years old. Comparability of the UK
educational levels to the US
system is unknown; but the author stated in the report, approximately 50% of
subjects had gone to a university or college and <20% had left school before
age 16.

Table 1. Demographics and follow-up
compliance of subjects

[No. (% of enrolled subjects)]

Variable

Treatment Group

Control Group

Enrolled Subjects

553

530

Recruited
after EC use

323
(58)

327
(62)

Recruited
after abortion

230
(42)

203
(38)

Lost
to Follow-up

34
(6)

44
(8)

Subjects with results available for analysis

549 (99)

522 (98)

Age (years)

<20

132
(24)

116
(22)

20–29

314
(57)

309
(58)

>30

107
(19)

105
(20)

Education

Age
full-time education ended

<
16 yr

93
(17)

92
(17)

17–18
yr

127
(23)

106
(20)

19–22
yr

116
(21)

114
(22)

≥
23 yr

54
(10)

61
(12)

Still
in school full time

154
(28)

145
(27)

Educational
status unknown

9
(2)

12
(2)

Data
were extracted from the author’s Table 1.

Follow-up Compliance

Approximately
98% of subjects had data available for analysis of pregnancy at the one-year
follow-up. Ascertainment methods included contacting the family doctor and the
Scottish Health Department.However,
only 64% the subjects in both groups (350 of 549 in the treatment group and 336
of 522 in the control group) were used for the final analyses of sexual and
contraceptive behaviors because they provided the responses to the detailed
questionnaire.

Changes in Contraceptive Behavior:

Sexual
and contraceptive behaviors of subjects from treatment and control groups at
the enrollment and one-year follow-up are summarized in Table 2.

EC
Use:

Women in the advance EC group were more likely to use
emergency contraceptives than those in control groups; 47% used EC at least
once in the treatment group vs. 27% in the control group at the one year
follow-up.The difference in single use
between groups (36% vs. 14%) was statistically significant (P<0.01).

The proportion of subjects in each arm who were recruited
after prior use of EC was 58% in the treatment group and 62% in the control
group.Comparison of multiple users was
not statistically different between treatment and control groups.

Condom
Use:

Condom uses similarly decreased in both arms.Condom use decreased from 74% at baseline to
31% at one year in the treatment group and from 70% at baseline to 28% at one
year in the control group.

Contraception
Methods

The proportion of oral contraception use increased
similarly in both groups.

Unprotected
Sex:

Data on unprotected sex were not provided in the report.
The “None contraception” shown in Table 2, which may include unprotected sex,
decreased in both group at one year follow-up.

Table 2. Contraceptive behavior of
subjects at enrollment and one year later

[No. (% of subjects who provided contraception data)]

Contraceptive Behavior

Treatment Group

N=350*

Control group

N=336*

At Enrollment

One Year Later

At Enrollment

One Year Later

Contraception Methods

Oral
contraception

45
(13)

169
(48)

46
(14)

171
(51)

Condom

258 (74)

108 (31)

235 (70)

94 (28)

Diaphragm

7
(2)

7
(2)

11
(3)

15
(4)

Combination

3
(1)

31
(9)

6
(2)

34
(10)

None

34
(10)

21
(6)

33
(10)

15
(4)

Other
or no answer

3
(1)

12
(3)

5
(1)

6
(2)

EC Use†

Did
not use

199
(53)

239
(73)

Used
once

135 (36)

45 (14)#

Used
twice

27
(7)

33
(10)

Used
3 times

13
(3)

8
(2)

Used
> 3 times

5
(1)

1
(<1)

Pregnancy‡

Total Pregnancies

28 (5)

33 (6)

Unintended Pregnancies

18 (3)

25
(5)

Abortions

15 (3)

19 (4)

* The number of subjects who responded to the question regarding the
method of contraception.

† Percentage was calculated based on the subjects who provided data,
379 in the Treatment group and 326 in Control group.

‡ Percentage was calculated based on the subjects who provided data,
549 in the Treatment group and 522 in the Control group.

#P < 0.001

COMMENTS

1.The study population may not represent an OTC setting
in US. Subjects were recruited from UK
clinics (60% of them previously used emergency contraception and 40% had an
abortion).Half of the subjects went to
college/university.

2.Only 64% of enrolled subjects provided data for
analysis.

3.A single course of EC was provided to the subjects in
the advance EC provision group but they could return for further Advance
Provisions after use of the single course.

CONCLUSION

1.Women with advance EC access were more likely to use
EC, and had lower frequency of “none” method of contraception compared to
baseline at one year.The control group
had a greater decrease in “none” method of contraception at one year compared
to baseline than the advance EC group.

2.Although 135 (36%) of the treatment group used the
advance supply of EC, only about half returned for subsequent provisions of
advanced supplies.

3.Oral contraception use increased in both groups and
condom use decreased in both group compared to baseline.

Literature
#7(vol 13, page 067a)

Provision of Emergency
Contraceptive Pills to Spermicide Users in Ghana

Sponsor:Family Health International (FHI) with funds
from the United States Agency for International Development (USAID).

Study Location: Africa,Planned Parenthood Association of Ghana

July 1998 - June
1999

Publication:Contraception 61:
287–293, 2000

Design:Nonrandomized clinical
trial

8 weeks follow-up

Single course of advance EC
provision, with opportunity to return for additional courses

METHODS

Subject

A total of 210 women spermicide users were recruited and
enrolled from 4 Planned Parenthood clinics (Accra,
Nkawkaw, Kumasi, Takoradi) in Ghana,
with the following eligibility criteria:

Age 18-45 years

No current pregnancy.

Spermicides as the
primary contraception method and EC as a backup method during the 8-week
study period

Expected to have at
least 6 coital acts per month

No history of
thromboembolic disease

Subjects
were counseled on the use of spermicide and given at least 40 spermicide
tablets, and then non-randomly assigned into the following 2 groups (2 clinic
sites each group):

Control
(On Demand Provision) Group: 100 subjects recruited from clinics in Kumasi
and Takoradi received EC education and advised to return to the clinic within 3
days after unprotected intercourse to obtain EC.

Advance
Provision Group: 110 subjects recruited from clinics in Accra
and Nkawkaw were given one packet of EC and advised to return to the clinic for
re-supply immediately if she used, lost, or gave away the ECPs. Subjects were
also asked to refill the ECPs at each of 2 visits.

Subjects returned to the clinics for follow-up visits at 4
and 8 weeks after enrollment to collect the following information: the reason
for EC use or EC request, the dates and times of unprotected sex, the
disposition of ECPs dispensed, side effects of ECPs, coital activity, and
contraceptive use.

Data Analysis

All
data were presented separately by clinics without any statistical analysis.

RESULTS

Subject Demographics and Follow-up
Compliance

Of
210 enrolled subjects, 95% (200) provided any follow-up information for
analyses. The duration of follow-up was 8.2-8.6 weeks per subject.

The
demographics of the enrolled subjects were summarized in Table 1. Differences
in the following characteristics of subjects were found among the 4 clinics:
age, education, marriage and condom use (unknown statistical significance).

Table 1. Demographics of enrolled
subjects

No. (% of enrolled subjects)

Characteristics

Advance
clinics

Control
clinics

Accra

Nkawkaw

Kumasi

Takoradi

Enrolled subjects

60

50

51

49

Age (years)

18–24

20 (33)

6 (12)

13 (25)

14 (29)

25–34

26 (43)

21 (42)

14 (27)

18 (37)

≥ 35

14 (23)

23 (46)

24 (47)

16 (33)

Education

None

3 (5)

6 (12)

11 (22)

3 (6)

Primary

14 (23)

9 (18)

21 (41)

1 (2)

Middle school

26 (43)

22 (44)

11 (22)

24 (49)

Higher

17 (28)

13 (26)

8 (16)

21 (43)

Marital status

Single

8 (13)

5 (10)

6 (12)

21 (43)

Married

52 (87)

45 (90)

45 (88)

28 (57)

Contraception in Past month

Spermicide

51 (85)

37 (74)

47 (92)

21 (43)

Oral contraceptive pills

4 (7)

10 (20)

0

1 (2)

Condom

14 (23)

2 (4)

2 (4)

11 (22)

Pregnancy History

Pregnancies (mean)

3.6

3.9

4.5

3.2

Living children (mean)

2.3

3.2

2.9

2.0

Miscarriages/abortions (mean)

1.3

0.7

1.4

1.1

Data
were extracted from the author’s Table 2.

Changes in Contraceptive Behavior

Sexual
and contraceptive behaviors of subjects before (one month) and after
(approximately 8 weeks) enrollment were summarized in Table 2.

Table 2. Sexual and contraceptive
behavior

Behavioral Variables

Advance Clinics

Control Clinics

Accra

Nkawkaw

Kumasi

Takoradi

Analyzed subjects

53

50

48

49

Mean Number of sex acts†

Month before enrollment

7.1

11.4

9.4

10.9

During study

18.1

24.3

18.4

24.6

Mean Unprotected sex acts‡

Month before enrollment

1.3

0.1

1.2

2.9

During study

1.2

0.1

0.2

0.1

EC Use during study (8
weeks)

Total subjects

48 (91)

6 (12)

14 (29)

6 (12)

0 use

5 (9)

44 (88)

34 (71)

43 (88)

1 use

26 (49)

5 (10)

10 (21)

6 (12)

2 uses

16 (30)

0

3 (6)

0

3 uses

6 (11)

1 (2)

1 (2)

0

Data
were extracted from the author’s Table 3 but re-processed/re-calculated.

Unprotected
sex: The mean number of sex acts per participant per month increased at
all clinic sites, but the proportion of acts that were unprotected declined..
This study was not randomized and there were imbalances between study sites in
many factors. Comparisons between Advanced Clinics and Controlled Clinics are
not valid.

EC
use: Subjects in Advance Clinics group seemed more likely to use EC
although this conclusion is powered by the Accura site. Repeat use was 8% in 3
clinical sites (41% in Accra site).

Condom
use: Changes on condom use was not assessed during the study.

Primary
contraception: Change in primary contraception (spermicide) before and
after enrollment, and the differences in primary contraception between Advance
and Control were not reported.

COMMENTS

1.Study has significant flaws; the assignment was not
randomized and there was great variability in demographics between the 4 clinic
sites.

2.Study subjects did not have access to other forms of
contraception.

3.The study was conducted outside US, and is not readily
generalizable to US
population, particularly an OTC setting.

4.A single course of EC was provided to the advance
provision group. Subjects were asked to receive refills of advanced EC.There was 41% of participants that had repeat
use at one advanced provision clinic and 2% at the other.This compared to 8% at one “on demand” clinic
and 0 % at the other “on demand” clinic.

5.There were 2 follow-up visits (weeks 4 and 8) during
the study. However, comparisons in sexual and contraceptive behaviors of
subjects between 2 visits were not reported.

CONCLUSION

1.Subjects with advance EC access were more likely to use
EC.

2.Behavioral changes between groups can not be assessed
due to significant deficiency in study design.

Literature #8(vol 13, page 011a)

Emergency Contraception:
Randomized Comparison of Advance Provision and Information Only

Subjects returned quarterly to the clinic for follow-up for
up to 1 year to collect information about frequency of unprotected intercourse,
EC use, pregnancies, and sexually transmitted infections.

RESULTS

Subject Demographics (Table 1)

The
mean age was 25 years, and approximately 5% of subjects were < 20 years old.
Comparability of the educational levels in India
to the US was
unknown; apparently, 84% of subjects completed ≥ 9 years education.

Table 1. Demographics and Follow-up
Compliance of Enrolled Subjects

Characteristics

Control

(n = 198)

Advance EC

(n = 213)

Age (years),No. (%)

< 20

10 (5)

9 (4)

20–29

166 (84)

172 (81)

> 30

22 (11)

32 (15)

Mean ±SD

24.9 (3.7)

25.1 (3.8)

Years of schooling,No. (%)

0–8

29 (15)

36 (17)

9–12

96 (48)

103 (48)

13–16

60 (30)

61 (29)

> 16

13 (7)

13 (6)

Mean ± SD

11.7 ± 3.5

11.4 ± 3.4

Follow-up Compliance†, No. (%)

Lost to Follow-up

45 (33)

34 (16)

3 months

172 (87)

194 (91)

12 months

66 (33)

99 (46)

Data
were adapted form the author’s Table 1, otherwise from Table 2 and Figure 1 (†).

Follow-up Compliance

Approximately
87% (172 in control group) and 91% (194 in advance EC group) of subjects
completed at least 3 months in study and available for analysis.Women who switched to non-barrier
contraceptives left the study.

Sexual and Contraceptive Behavior (Table 2)

Unprotected sex: Women with advance EC provision did not have
statistically greater frequency of unprotected sex and a similar proportion of
women on the two study arms reported unprotected sex during the study, 8% in
the advanced provision vs. 6% in the control group.

EC use: Women with advance EC provision were more likely to use
EC pills (79% vs 44%) after unprotected intercourse(Eleven (5%) EC users were
in the Advanced Provision group and four (2%) in the control group)..

Condom use: The study subjects used condom as a primary
contraception method and 23% in both arms went off study because they changed
to a more effective contraceptive method.Ninety-eight percent of women in the advanced supply arm stated that
availability of EC did not “tempt them to talk changes with their condoms”.

STDs: one subject reported an STD. Details of the STD (nature
and study group) were not provided in the report. STDs were self reported and
no clinical laboratory screening was performed.

Table 2. Unprotected
sex and Emergency contraceptive Use

(Excluded 24 subjects who
left the study)

Unprotected Intercourse

Control

Advance EC

P value

Mean number of unprotected sex acts per

month among all women followed

0.016

0.012

0.62

Median number of unprotected sex acts per

month among women with at least

one unprotected sex

0.250

0.292

0.97

Number of women, no. (%)

9/157 (5.7)

14/185 (7.6)

0.53

EC use, no. (%)

4/9 (44.4)

11/14 (78.6)

0.18

Data
were adapted from the author’s Table 3.

COMMENTS

It
is not clear if the rate of unprotected sex changed from baseline since
baseline information (at the enrollment) was not provided.

The
study was conducted in India,
which is unlikely to be representative of US
population.

CONCLUSION

Advance EC provision did not appear to increase the
frequency of unprotected sex as compared to control in the population who used
condom as a primary contraception method.The proportion of participants who did have unprotected sex who used EC
was higher in the Advanced EC group.